(84 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or specific AI/ML-driven image processing techniques. The description focuses on standard MR hardware and imaging capabilities.
No
The device is described as a "magnetic resonance diagnostic device (MRDD)" and its purpose is to "assist in diagnosis" by producing images. It is not indicated for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "magnetic resonance diagnostic device (MRDD)" and that its output "may assist in diagnosis."
No
The device description explicitly states it is a "1.5 T closed superconducting magnet designed scanner" and lists hardware components like a magnet, gradient coil, and RF body resonator. This indicates it is a hardware device, not software-only.
Based on the provided information, the MAGNETOM Espree is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device produces images and/or spectra of the internal structure and/or function of the head, body, or extremities. This is a description of an in vivo diagnostic device, meaning it is used to examine the body directly.
- Device Description: The description details a magnetic resonance scanner, which is a type of imaging equipment used on living patients.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue) outside of the body, which is the defining characteristic of an in vitro diagnostic device.
Therefore, the MAGNETOM Espree is an in vivo diagnostic device, specifically a Magnetic Resonance Diagnostic Device (MRDD).
N/A
Intended Use / Indications for Use
The MAGNETOM Espree is indicated for use as magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM Espree may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR safe biopsy needles.
Product codes (comma separated list FDA assigned to the subject device)
90 LNH, LNI
Device Description
The MAGNETOM Espree System is a 1.5 T closed superconducting magnet designed scanner. It consists of the same types of hardware (with a modified gradient coil. RF body resonator and magnet) that is currently available with MAGNETOM Avanto.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
magnetic resonance
Anatomical Site
head, body, or extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
JUL 2 1 2004
Section 2: 510(k) Summary
Kof1112
SECTION 2: 510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92.
I. General Information
| Establishment | Siemens Medical Solutions, Inc.
51 Valley Stream Parkway
Malvern. PA 19355 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration Number | 2240869 |
| Manufacturer | Siemens AG. Bereich Med
Henkestrasse 127
D-91052 Erlangen. Germany |
| Registration Number | 8010024 |
| Contact Person | Ms. Nealie Hartman
Technical Specialist. Regulatory Submissions
51 Valley Stream Parkway E50
Malvern. PA 19355
Phone: (610) 448-1769
Fax: (610) 448-1787 |
| Device Name | Trade Name: MAGNETOM Espree System
Classification Name: Magnetic Resonance Diagnostic Device
CFR Code: 21 CFR § 892.1000
Classification: Class II |
Performance Standards
None established under Section 514 the Food, Drug and Cosmetic Act.
1
II. Safety and Effectiveness Information Supporting Substantial Equivalence.
Intended Use
The MAGNETOM Espree is indicated for use as magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM Espree may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR safe biopsy needles.
Device Description
The MAGNETOM Espree System is a 1.5 T closed superconducting magnet designed scanner. It consists of the same types of hardware (with a modified gradient coil. RF body resonator and magnet) that is currently available with MAGNETOM Avanto.
Substantial Equivalence
The system is substantially equivalent to the following cleared medical devices:
| Predicate Device Name | FDA Clearance
Number | FDA Clearance
Date |
|-------------------------|-------------------------|-----------------------|
| Siemens MAGNETOM Avanto | K032428 | October 16, 2003 |
General Safety and Effectiveness Concerns:
Operation of the MAGNETOM Espree System is substantially equivalent to the commercially available MAGNETOM Avanto. Specified by the FDA guidance document for MR Diagnostic Devices that will be evaluated, below are the safety parameter with the following levels:
Action Levels
- · Maximum Static Field
- · Rate of Change of Magnetic Field
- · RF Power Deposition
- · Acoustic Noise Levels
Performance Levels
- · Signal to Noise
- · Image Uniformity
- · Geometric Distortion
- · Slice Profile. Thickness and Gap
- · High Contrast Spatial Resolution
The MAGNETOM Espree will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the international IEC standard for safety issues with Magnetic Resonance Imaging Devices. This will assure that the performance of this device can be considered safe and effective with respect to the currently available MAGNETOM Avanto.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle, emphasizing the organization's name and purpose.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 1 2004
Ms. Nealie Hartman Technical Specialist Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway MALVERN PA 19355
Re: K041112
Trade/Device Name: MAGNETOM Espree Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH and LNI Dated: April 26, 2004 Received: April 28, 2004
Dear Ms. Hartman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms lotter notification. The FDA finding of substantial equivalence of your device to a legally promaticated predicated device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you dosh o spoolite at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4597 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4697 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. brigden
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number (if known)______________________________________________________________________________________________________________________________________________________
Device Name: MAGNETOM Espree
Indications for Use:
The MAGNETOM Espree is indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, (MIOD) that produce trans spectra, and that display the internal structure and/or function of spectiossopic integoedialities. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM Espree may also be used for imaging during interventional procedures The MITORET ON ESPEC And as in room display as, in room display and MR safe biopsy needles.
(please do not write below this line- continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation
Prescription Use_ V
Over-The-Counter Use __
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
CONFIDENTIAL